The Journal of Infectious Diseases

SUPPLEMENT ARTICLE

The Effectiveness of Varicella Vaccine: 25 Years of

Postlicensure Experience in the United States
Eugene D. Shapiro1,2 and Mona Marin3
1
Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA; 2Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven,
Connecticut, USA; and 3Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

We summarize studies of varicella vaccine’s effectiveness for prevention of varicella and lessons learned during the first 25 years of the

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varicella vaccination program in the United States. One dose of varicella vaccine provided moderate protection (82%–85%) against
varicella of any severity and high protection (100%) against severe varicella, with some waning of protection over time. The 1-dose
program (1995–2006) had a substantial impact on the incidence both of varicella and of severe outcomes (71%–90% decrease)
although it did not prevent low-level community transmission and some outbreaks continued to occur in highly vaccinated
populations. Two doses of varicella vaccine improved the vaccine’s effectiveness by at least 10% against varicella of any severity,
with further declines in the incidence both of varicella and of severe outcomes as well as in both number and size of outbreaks.
There is no evidence for waning of the effectiveness of 2 doses of the vaccine.
Keywords. varicella vaccine; effectiveness; varicella; epidemiology.

Prior to licensure, vaccines must be shown to be both safe and ef­
ficacious. This is achieved through phased, randomized, double-
blinded controlled clinical trials designed to minimize bias with
respect to both receipt of the vaccine and assessment of outcomes.
Clinical trials of the varicella vaccine were conducted in the
United States in the 1980s and early 1990s using dosages of the
Oka/Merck live attenuated varicella-zoster virus (VZV) that var­
ied from <500 to 17 430 plaque-forming units (pfu)/dose [1]. The
currently licensed vaccine contains a minimum of 1350 pfu/dose
at expiration [2] (range 3000–17 000 pfu/dose at release) [1]. The
double-blinded, placebo-controlled efficacy trial that was
conducted in healthy children who had not had varicella
contained 17 430 pfu/dose [2, 3]. After 2 years of follow-up, the
vaccine’s efficacy was 98% overall and 92% after household
exposure [4].
After a vaccine is licensed, assessing the protective effective­
ness of the vaccine under conditions of real word use is a critical
component of monitoring a vaccine program and these data
may inform revisions of vaccine policy [5, 6]. This is because
clinical trials are generally conducted under ideal conditions
(eg, vaccine is stored properly and is administered correctly
with specifically designated timing, all of which may not occur
in real world circumstances). In addition, cases typically are
laboratory confirmed, which improves the specificity of the
Correspondence: E. Shapiro, MD, Yale Department of Pediatrics, PO Box 208064, New
Haven, CT 06520-8064 (eugene.shapiro@yale.edu).
The Journal of Infectious Diseases® 2022;226(S4):S425–30
© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases
Society of America. All rights reserved. For permissions, please e-mail: journals.permissions
@oup.com
https://doi.org/10.1093/infdis/jiac299
case definition. However, subjects who have underlying illness­
es that decrease the likelihood that they will respond adequately
to the vaccine (eg, immunocompromised patients) are often ex­
cluded, even though such patients may be at highest risk of seri­
ous disease from infection. This and other factors may impair the
generalizability of the results of a clinical trial to a larger target
population. In addition, such trials are generally of relatively
short duration and typically do not address questions such as
the duration of protection provided by the vaccine and its
efficacy in specific subgroups of patients (eg, patients without a
spleen) or in certain outbreak situations (eg, a school or a day
care setting).
Varicella vaccine was first approved for use in the United
States in 1995, with 1 dose recommended for routine vaccina­
tion of children aged 12–18 months and catch-up vaccination
of children aged 19 months to 12 years who had not had vari­
cella [7]. Two doses, 4–8 weeks apart, were recommended for
susceptible children ≥13 years of age and for susceptible adults
with close contact with persons at high risk for severe disease
(eg, health care workers and family members of immunocom­
promised persons). In 2007, vaccine policy was revised and
2 doses were recommended routinely for children, adminis­
tered at age 12–15 months and at 4–6 years, with expansion
of recommendations for other subgroups [8]. There are 2 var­
icella vaccines currently available for use in the United States, a
single antigen varicella vaccine (VARIVAX [VAR], licensed in
1995), and a combination measles, mumps, rubella, and vari­
cella vaccine (MMRV, licensed in 2005). Both contain the
Oka/Merck strain of live attenuated varicella-zoster virus [2,
9]. Seward et al and more recently Marin et al provided an in-
depth summary and meta-analysis, respectively, of published

Varicella Vaccine Postlicensure • JID 2022:226 (Suppl 4) • S425

studies of varicella vaccine’s effectiveness (VE) [10, 11].
Because little new information has become available since the
last analysis, here we review and provide a commentary on
the experiences and lessons learned during the first 25 years
of the US vaccination program from assessments of the effec­
tiveness of 1 dose and of 2 doses of varicella vaccine for preven­
tion of varicella.
METHODS TO ASSESS A VACCINE’S EFFECTIVENESS
Ultimately, the impact of a vaccine on a population will depend
on the protective effectiveness of the vaccine, the proportion of
the population that has received the vaccine, and sometimes
other factors such as the vaccine’s effect on colonization and/
or transmission of the targeted pathogen. The effectiveness of
a vaccine is measured by examining the reduction in the inci­
dence of infection (which could be defined as any infection,
symptomatic infection, severe infection, etc.) that is attribut­
able to the vaccine [6, 12]. This can be achieved using observa­
tional studies and, for VE of VAR, a variety of study methods,
including the screening method, case-control studies, and co­
hort studies (prospective, retrospective, or a combination in­
cluding outbreak investigations and studies of secondary
attack rates in households) have been employed [10, 11].
Outcomes of studies of VE of VAR have included both
laboratory-confirmed and clinically diagnosed varicella.
Severity of varicella has most commonly been defined as
mild, moderate, or severe according to the number of skin le­
sions (mild, <50 lesions; moderate, 50–499 lesions; and severe,
≥500 lesions or the occurrence of either complications or hos­
pitalization) [10, 11]; some studies used a disease-severity score
modified from the clinical trials [13, 14]. All observational
study designs are potentially subject to both confounding and
bias, but there are measures that can be taken in observational
studies to try to minimize confounding and bias and to assess
the degree to which confounding and bias might affect the re­
sults [15, 16]. Case-control studies have an advantage in that
they are statistically very powerful for rare outcomes compared
with longitudinal cohort studies, but may have additional asso­
ciated biases (eg, selection bias or detection bias).
EFFECTIVENESS OF 1 DOSE OF VARICELLA VACCINE
During the first decade of the US varicella vaccination program
(1995–2006), 1 dose of VAR was routinely recommended for
children ≤12 years of age. Assessments of VE of VAR occurred
as vaccine coverage increased and outbreaks in day care centers
and in elementary schools provided opportunities to study how
the vaccine was working in preventing clinically diagnosed var­
icella and its consequences [10, 11]. A postlicensure case-
control study was also conducted in pediatric practices from
1997 to 2003 and examined VE of VAR against laboratory-
confirmed disease and the effectiveness of the vaccine over
S426 • JID 2022:226 (Suppl 4) • Shapiro and Marin
time [13, 14]. An active surveillance area for varicella also pro­
vided the opportunity to conduct a large household contact VE
study [17]. A review of 17 published studies from 1995 to 2006
found that 1 dose of VAR was 84.5% effective (median range,
44%–100%) in preventing varicella of any severity and 100% ef­
fective (median and mean) in preventing severe varicella [10].
Most of these studies were outbreak investigations in either
childcare centers or schools. The case-control study (in which
infection was confirmed by polymerase chain reaction [PCR]
assay of specimens from skin lesions in the cases) found that
1 dose of VAR was 85% effective (95% confidence interval
[CI], 78%–90%) in preventing any varicella and was highly ef­
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fective (VE, 97%; 95% CI, 93%–99%) in preventing moderate/
severe varicella [13]. A continuation of this study through June
2003 found that there was a substantial decrease in the effec­
tiveness of 1 dose of the vaccine in the second year after immu­
nization, but little change in its effectiveness for the subsequent
7 years [14]. The vaccine’s effectiveness against laboratory-
confirmed varicella of any severity was 97% (95% CI,
91%–99%; P < .001) in the first year after immunization but
fell to 84% (95% CI, 76%–89%; P < .001) in years 2 through 8
after immunization (P = .003 for the difference). A household
contact study, which provides the best test of a vaccine’s effec­
tiveness under conditions of almost certain intense exposure,
and with a high probability of equal opportunities for exposure
for both vaccinated and unvaccinated household contacts,
found that 1 VAR dose was 78.9% effective (95% CI,
69.7%–85.3%) in preventing varicella of any severity and was
92% and 100% effective for prevention of moderate and severe
disease, respectively [17]. Finally, a recent meta-analysis found
a pooled VE of 24 studies of 1 dose of VAR of 82% (95% CI,
79%–85%) for prevention of varicella of any severity and of
98% (95% CI, 95%–99%) for prevention of moderate or severe
disease [11]. All except 2 of these studies were conducted in the
United States.
A large study in a varicella active surveillance area examined
whether the severity and incidence of varicella among vaccinat­
ed children (breakthrough varicella) increased with the time
since vaccination [18]. The authors found that the annual
rate of breakthrough varicella was low and increased signifi­
cantly with the time since vaccination, from 1.6 cases per
1000 person-years (95% CI, 1.2–2.0) within 1 year after vacci­
nation to 9.0 per 1000 person-years (95% CI, 6.9–11.7) at
5 years and 58.2 per 1000 person-years (95% CI, 36.0–94.0)
at 9 years. They also determined that children between the
ages of 8 and 12 years who had been vaccinated at least 5 years
previously were significantly more likely to have moderate or
severe disease (based on the number of skin lesions) than
were those who had been vaccinated less than 5 years previous­
ly (risk ratio, 2.6; 95% CI, 1.2–5.8).
In addition to studying possible waning of vaccine-induced
immunity by analyzing VE or the rate of breakthrough varicella
according to time since vaccination, the studies of the 1-dose pe­
riod also examined several other potential risk factors for vaccine
failure, including age at time of vaccination, presence of an under­
lying medical condition such as asthma or eczema, receipt of ste­
roids around the time either of vaccination or of exposure to
disease, and problems with storage and handling of this heat-labile
vaccine [10]. There were no consistent risk factors identified and
most did not have sufficient sample sizes for independent assess­
ment of risk factors that may be highly correlated, such as age at
time of vaccination and time since vaccination [10]. Additionally,
there was evidence for failure to induce an immune response as a
cause of breakthrough varicella; 1 small study reported that up to
24% of vaccinated healthy young children (median age at vaccina­
tion 12.5 months) did not have protective levels of antibodies an
average of 4 months after vaccination [19].
The impact of an effective vaccine depends on how many
susceptible people in a population are vaccinated as well as
its effects on transmission of varicella in the community. In
the United States, vaccine coverage among children aged
19–35 months increased steadily to reach 90% by 2007 [20].
The impact of the vaccine was readily apparent within the first
5 years of the program, with substantial declines in the inci­
dence of varicella and in the frequency of severe disease (hos­
pitalizations and deaths) [21–23]. The incidence of varicella
declined in all age groups, including in infants who were too
young to be vaccinated and in adults, which reflects indirect
protection from the vaccine because of decreased frequency
of exposure to disease [21, 24]. Over the entire duration of
the 1-dose program, incidence, hospitalization, and deaths
from varicella declined by 71%–90% [24–26]. However, even
when uptake of the vaccine among toddlers exceeded 90%
and the incidence of varicella had decreased by about 90%,
the virus continued to circulate at low levels in the community,
with the number of reported cases leveling off [8, 27].
Moreover, some varicella outbreaks continued to occur in
highly vaccinated populations, primarily in school settings
[28–30]; the outbreaks were smaller and less frequent than in
the prevaccine era [31], but nevertheless required control mea­
sures to prevent further transmission. Vaccinated children with
breakthrough varicella, although less contagious than unvacci­
nated persons with varicella, could still transmit the virus to
susceptible persons [8, 17, 28, 30, 32] including, in 1 document­
ed instance, to an adult who died [8]. These findings provided
key epidemiologic evidence for revising vaccine policy recom­
mendations, and a change to a routine 2-dose program for all
children was recommended in 2007 [8, 27].
EFFECTIVENESS OF 2 DOSES OF VARICELLA
VACCINE
Assessment of the effectiveness of 2 doses of VAR continued
after initiation of the routine 2-dose program for children. In
the global meta-analysis study that summarized 8 VE esti­
mates (6 from studies conducted in the United States), the
pooled estimate of the effectiveness of 2 doses of VAR against
varicella of any severity was 92% (95% CI, 88%–95%) and
again was not significantly different by study design [11]. A
continuation of the previously described case-control study
found that from July 2006 to January 2010, of 71 children
with PCR-documented varicella, none had received 2 doses
of VAR [33]. In the same study, the effectiveness of 1 dose
of VAR was similar to that found in the earlier case-control
study (86%, although the 95% CI was very wide because of
the small number of subjects that had received only 1 dose
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of the vaccine). However, 2 doses of the vaccine were 98% ef­
fective (95% CI, 84%–100%) in preventing varicella of any se­
verity and were statistically significantly more effective than
1 dose of the vaccine (P < .001). To minimize bias in the case-
control study, the authors used matching and conditional lo­
gistic regression to control for potential confounders. Even
though there was a substantial difference in the proportions
of cases and of controls that had received VAR (from which
the VE estimates were derived), there was virtually no differ­
ence in the proportions of cases and of controls that had re­
ceived measles, mumps and rubella vaccine, a vaccine that is
recommended to be administered at the same ages as varicella
vaccine, which suggested that selection bias did not affect the
results. One study published after the meta-analysis study also
reported a VE of 2 doses of VAR that was similar to the pooled
estimate, with 94% effectiveness (95% CI, 76%–98%) against
varicella of any severity and 98% effectiveness (95% CI,
83%–100%) against moderate or severe varicella, while the ef­
fectiveness of 1 dose of VAR was 76% (95% CI, 39%–90%) in
preventing any clinically-diagnosed varicella [34]. Two stud­
ies examined protection of 2 VAR doses by time since vacci­
nation and reported either no difference in VE [35] or no
association with breakthrough varicella [34] through 5 years
after the second dose.
The 2-dose vaccine program in the United States has had a
substantial impact on further reducing the incidence both of
varicella and of severe outcomes (≥94% during the entire vac­
cination program, 1995–2019), with a substantial decrease in
breakthrough varicella and in the number of outbreaks report­
ed in congregate settings [36–38]. Declines were seen during
the first 5 years of the 2-dose program when the reported inci­
dence of varicella declined to the lowest level since 1995, with
additional declines in varicella hospitalizations as well [39].
The greatest declines in incidence occurred in the age groups
for which the second dose was recommended.
LESSONS LEARNED AND CONCLUSIONS
Experience with monitoring VAR VE in the United States from
1996 to 2020 has demonstrated that 1 dose of VAR provided
Varicella Vaccine Postlicensure • JID 2022:226 (Suppl 4) • S427
moderate protection (82%–85%) against varicella of any se­
verity and high protection (100%) against severe varicella in
children, with some waning of vaccine-induced protection
over time [10, 11]. The 1-dose program had a substantial im­
pact on reducing the incidence both of varicella and of severe
outcomes [22, 24–27] in all age groups, although it did not in­
duce sufficient population immunity to prevent low-level
community transmission, and some outbreaks continued to
occur in highly vaccinated elementary school populations
[28–30, 32]. These outbreaks were disruptive for both congre­
gate settings and parents and efforts to control outbreaks
placed both a financial burden and a strain on resources on
both state and local health departments. In addition, transmis­
sion could occur from children with breakthrough varicella to
susceptible high-risk close contacts. These and other data on
the improved immune response to a second dose of VAR in
children [40] informed a change in vaccine policy in 2007 to
a 2-dose program [8, 27]. There is some controversy about
whether the decreased effectiveness of varicella over time was
due to secondary vaccine failure (waning of immunity over
time) or to primary vaccine failure (failure to induce a sus­
tained protective immune response in at least a subset of vacci­
nees); it may be a combination of the two. The fact that varicella
in vaccinated persons is usually mild with a considerably mod­
ified clinical presentation [41] suggests partial protection or in­
adequate induction of a totally protective immune response
rather than primary vaccine failure. The vaccination program
did not lead to an increase in the burden of varicella among ei­
ther adults or pregnant women. Studies of the effectiveness of
2 doses of VAR confirmed improved VE of least 10% against
varicella of any severity [11], which was reflected in further de­
clines in the incidence both of varicella and of severe outcomes
as well as in the number and the size of outbreaks after imple­
mentation of the 2-dose program [36–38].
In the United States, studies of the effectiveness of MMRV
vaccine for preventing varicella have not been conducted.
MMRV vaccine became available at the end of the 1-dose pro­
gram when the number of cases of varicella was already very
low and, due to an increased risk of febrile seizures in children
12–15 months of age who received MMRV vaccine, it is now
predominantly used for the second dose in children 4–6 years
of age [42]. Studies are needed on the effectiveness of varicella
vaccines in preventing herpes zoster (HZ); there is strong epi­
demiological evidence of a lower risk of HZ in vaccinated chil­
dren than in those who had varicella, either an approximately
80% lower risk of HZ [43, 44] or a decline in HZ incidence as
the child and adolescent cohorts started being comprised pri­
marily of vaccinated persons who were born after the varicella
vaccination program had begun [45, 46]. To date, there is no
epidemiological evidence of waning of the VE of 2 doses of
the vaccine. The incidence of varicella, as well as of both hospi­
talizations and deaths because of varicella, have continued to
S428 • JID 2022:226 (Suppl 4) • Shapiro and Marin
decline over the 25 years of the varicella vaccination program
[37, 38]. Assessment of the VE for prevention of varicella
should continue as vaccinated children age into adulthood.
Notes
Acknowledgment. We thank Dr Jane Seward for feedback on
manuscript concept and review.
Disclaimer. The findings and conclusions in this report are
those of the authors and do not necessarily represent the official
position of the Centers for Disease Control and Prevention.
Financial support. No financial support was received for this
work.
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Supplement sponsorship. This supplement is sponsored
by the Centers for Disease Control and Prevention, Atlanta,
GA, USA.
Potential conflicts of interest. All authors: No reported con­
flicts. All authors have submitted the ICMJE Form for
Disclosure of Potential Conflicts of Interest. Conflicts that the
editors consider relevant to the content of the manuscript
have been disclosed.
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